Kornimate/medical-research-clean huggingface dataset:
tavns treatment for fibromyalgia

Conditions: Fibromyalgia

Summary: in this research study we want to learn more about if transcutaneous electrical nerve stimulation (tens), a safe electrical stimulation tool, can relieve fibromyalgia pain. a total of 60 subjects with fibromyalgia will be enrolled in this study at massachusetts general hospital, charlestown navy yard campus.


Eligibility criteria:
inclusion criteria: * meet the american college of rheumatology (acr) 1990 classification criteria and the acr 2010 diagnostic criteria for fibromyalgia as determined by clinicians. * willingness to complete a 4-week, twice-a-day treatments. * at least a 10th grade english-reading level; english can be a second language provided that the patients understand all questions used in the assessment measures. exclusion criteria: * diagnosed with medical conditions that are known to contribute to fibromyalgia symptomatology, such as thyroid disease, inflammatory arthritis, systemic lupus erythematosus, rheumatoid arthritis, myositis, vasculitis, or sjogren's syndrome. * history of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome. for example: asthma or claustrophobia. * personal history of medical or psychiatric illness as determined by investigator. * pregnant or lactating. * less than a 10th grade english-reading level; english can be a second language provided that the patients understand all questions used in the assessment measures.

Keywords: tavns pain neuromodulation fibromyalgia
lung cancer screening implementation among employees at lyon hospital

Conditions: Lung Cancer

Summary: several randomized studies have demonstrated the efficiency of lung cancer screening (lcs) on mortality rates. however, screening efficiency is related to the targeted population and the participation rate. in france, the participation rate for breast and colon cancer screening programs is respectively 50% and 32%, which is low. then, it appears very important to determine which factors are influencing the willingness to participate to these programs. indeed, it will allow a better communication and we will be able to perform screening campaigns adapted to the eligible population. the lyon hospital is the second university hospital in france. it is composed of 14 buildings and employed 23 000 persons. more than 160 occupations are represented. so, hospital employees look relevant to be studied for lcs program. ilyad was divided in 2 parts. the first one was completed in 2020 and goal to evaluate the number of eligible individuals among the hospital employees. about 800 persons would be eligible for lcs. this second part of the study will evaluate the participation rate and the feasibility of the lcs program. the study will target the 800 individuals that were identified previously.


Eligibility criteria:
* inclusion criteria : * participant have to meet the criteria below: lyon hospital employee at the day of inclusion: * valid hospital employee number, * or retired employee for less than a year before the inclusion and meeting eligibility criteria as follow : * aged from 50 to 75 yo, * and smoke or have smoked ≥ 10 cigarettes/day during ≥ 30 years or ≥ 15 cigarettes/day for at least 25 years; * and active smoker or smoking cessation for ≤ 15 years ; * volunteer to start a program of smoking cessation if active smoker; * consent form signed ; * cover by health insurance. * exclusion criteria : participant have to not meet the criteria below : * individual not working at lyon hospital; * individual not payed by the lyon hospital but working at it; * individuals not willing to participate; * individual working at rené sabran hospital; * individual meeting one of this non eligibility for lcs criteria defined by the french recommendation: * not able to climb 2 floors of stairs ; * weight ≥ 140kg * underwent a chest ct scan less than 1 year ago (except screening scanner); * history of lung cancer of less than 5 years or under treatment ; history of any cancer under monitoring by chest scanner ; * comorbidity contraindicating therapeutic options or any kind of invasive interventions ; * ongoing or recent respiratory symptoms that might lead to lung cancer diagnosis (hemoptysia, weight loss, recurrent respiratory infection). * individual who is pregnant or breast feeding; * individual whose mental health is not good enough to participate; * individual in jail or under justice evaluation.

Keywords: lung cancer screening tobacco cessation copd
a comparison of long-term effectiveness of two desensitizing products

Conditions: Dentin Hypersensitivity

Summary: this randomized, controlled, clinical trial aimed to compare the 6- month clinical performance of a desensitizer that contains calcium phosphate tm with a two-step self-etch adhesive se and placebo (distilled water). at least 150 teeth wil be treated with desensitizing products and placebo randomly one third usig tm, one third using se and one third using placebo. the efficiency of the materials will be evaluated at baseline, 1 week, 1 month, 3 months and 6 months after treatment.

the aim of this randomized, controlled, clinical trial is to compare the clinical efficacy of a desensitizer that contains calcium phosphate with a two-step self-etch adhesive and placebo through a long-term period (6 months). at least fifty patients with a sensitivity score of 6 or higher, according to the visual analog scale (vas), with at least three teeth will participate in this study. teethmate desensitizer (tm), clearfil se bond 2 (se) and placebo (distilled water) will be applied randomly to three teeth of each patient. recalls will be done at baseline, 1 week, 1 month, 3 months and 6 months after treatment by applying air-blast and the sensitivity scores will be determined according to vas. the efficiency of the materials will be determined according to the vas scores. data will be analyzed using paired t test and repeated measures of anova.

Eligibility criteria:
inclusion criteria: 1. subjects with 3 or more hypersensitive teeth with a vas (visual analog scale) score 2. willingness to participate in the study exclusion criteria: 1. subjects are unwilling to participate voluntarily 2. patients under 18 years old 3. those that were taking analgesic medicaments 4. pregnant and breastfeeding females 5. the presence of a systemic disease that affects the participation 6. teeth with cervical loss of hard tissue that need restoration absolutely 7. large/defective restoration, caries or enamel cracks in sensitive teeth 8. teeth with vulnerability to hypersensitivity after root scaling 9. pulpitis presence.

Keywords: dentin hypersensitivity randomized clinical trial calcium phosphate desensitizer adhesive resin vas
professional quality of life in german mental health nursing

Conditions: Mental Disorder; Burnout, Professional; Burnout, Caregiver

Summary: the purpose of this study is to assess professional quality of life in german nurses working with patients with mental disorders.

the purpose of this study is to assess professional quality of life, which includes compassion satisfaction, burnout and secondary traumatization in nurses, working with patients with mental disorders, in germany.

Eligibility criteria:
inclusion criteria: * nurse * currently working with patients with mental disorders * at least 18 years old * sufficient german skills for answering the questionnaire exclusion criteria: none

Keywords: professional quality of life compassion satisfaction burnout nursing mental disorder mental health
the effectiveness of a mindfulness application on perceived stess

Conditions: mHealth; Mindfulness; Stress; Burnout

Summary: mindfulness has become increasingly popular and positive outcomes have been reported for mindfulness-based interventions (mbis) in reducing stress. the aim of this study is to investigate if a non-guided mindfulness mobile phone application can decrease perceived stress in a non-clinical dutch population over the course of eight weeks, with follow-up at six months.

background: mindfulness has become increasingly popular and positive outcomes have been reported for mindfulness-based interventions (mbis) in reducing stress. these findings make room for innovative perspectives on how mbis could be applied, for instance through mhealth. objectives: the aim of this study is to investigate if a non-guided mindfulness mobile phone application can decrease perceived stress in a non-clinical dutch population over the course of eight weeks, with follow-up at six months. methods: a randomized controlled trial (rct) was performed, comparing the experimental group that made use of a structured 8-week mhealth mindfulness program and a control group after 8 weeks, with follow-up after six months. participants were recruited via a national television program. the primary outcome measure was perceived stress as measured by the perceived stress scale (pss), secondary outcomes were symptoms of burnout (vas) and psychological symptoms (measured by the four-dimensional symptom questionnaire ; 4dsq at follow-up). outcomes were analyzed using a multilevel regression model.

Eligibility criteria:
inclusion criteria: \>18 years exclusion criteria: there were no other eligibility criteria
physical activity and cognitive behavioural therapy in panic disorder

Conditions: Panic Disorder

Summary: physical activity (treadmill) supports the effect of cognitive behavioural therapy in patients with panic disorder with/without agoraphobia

patients undergo cognitive behavioural therapy consisting of 8 group sessions within 1 month. all patients additionally complete a training of physical activity, which starts simultaneously to therapy and runs for 8 weeks (3 times/week, 30 minutes each). half of the patients complete training on a treadmill while the other half completes a training programme of low intensity physical activity without cardiovascular activation. flanking eeg (electroencephalogram) recordings shall help clarify biological processes underlying the therapeutical process.

Eligibility criteria:
inclusion criteria: 1. subject familiarized with experimental procedure and had given written informed consent 2. diagnosis of panic disorder with or without agoraphobia according to diagnostic and statistical manual of mental disorders (dsm-iv) 3. sufficiently able to communicate with investigator, answer questions and fill in questionnaires 4. reachability of patient for treatment and follow-up exclusion criteria: 1. other psychiatric illnesses like schizophrenia, substance abuse or severe depressive episode 2. acute suicidal tendency 3. epilepsy or other illness of the central nervous system (e.g. brain tumor, encephalitis) 4. existence of contraindication against physical exercise 5. pregnancy or breastfeeding 6. changes of psychopharmacological treatment within the last 4 weeks

Keywords: panic disorder physical activity
evaluation of the patellar lift system for subjects with patellofemoral cartilage degeneration

Conditions: Patellofemoral Osteoarthritis

Summary: the pelican study is a prospective, non randomized, dual arm, multi-center clinical study comparing clinical outcomes of subjects treated with the lift implant system to subjects treated with tibial tubercle osteotomy (tto).


Eligibility criteria:
inclusion criteria: 1. patients age 22 to 65 years at time of screening 2. anterior knee pain due to patellofemoral cartilage degeneration (pcd) with an modified outerbridge score of ≥3 as assessed by an mri on the study knee 3. body mass index (bmi) of ≤ 35 4. weight \< 300 lbs 5. anterior knee pain score (akps) of ≤ 70 (0-100 scale) 6. visual analog score (vas) of ≥ 40 (0-100 scale) 7. failure of at least 6 months of non-surgical treatment defined as at least one of the treatments (e.g. rest, bracing, physical therapy, targeted exercise, use of nsaids, activity level reduction or confidential zkr orthopedics, cip 0001 page 11 of 55 protocol version: 1.0, 04jan2024 modification, etc.) per aaos treatment of osteoarthritis of the knee; evidence based guideline 3rd edition 2021 exclusion criteria: 1. pcd with an modified outerbridge score of 2 or less at the study knee 2. clinical symptoms of the contralateral knee that preclude activities of daily living, stair climbing, stair descending, or require the use of an assist device 3. history of patella dislocation or instability 4. patella alta or patella baja 5. known tt-tg distance \>20mm 6. patients requiring simultaneous cartilage grafting procedure, cartilage transplantation, or bone marrow stimulation 7. previous repair of a torn patellar tendon 8. prior tto procedure or knee joint replacement (total or partial) of the study knee 9. joint modifying surgery (e.g., ligament reconstruction, meniscus repair, cartilage transplantation, microfracture, etc.) in the study knee within 6 months prior to planned index procedure date 10. arthroscopic surgeries in the study knee for joint lavage, meniscectomy, chondral debridement, and loose body removal within 3 months prior to planned index procedure 11. active infection, sepsis, osteomyelitis or history of septic arthritis in any joint 12. rheumatoid arthritis, other forms of inflammatory joint disease or autoimmune disorder 13. history of avascular necrosis of any bone 14. history of symptomatic patellar tendonitis of intrasubstance tear 15. insufficiency of the cruciate, collateral ligaments, or tendon which would preclude stability of the lift system 16. pathologic ligamentous injury (lachman \> 1) or meniscus tearing 17. clinical symptoms of the femoral-tibial joint of the study knee that preclude activities of daily living, stair climbing, stair descending, or requires the use of an assist device 18. evidence (mri, arthroscopy, etc.) of modified outerbridge grade 4 degenerative arthritis in the femoral-tibial joint of the study knee that potentially explains patient symptoms
altargo(retapamulin) pms(post-marketing surveillance)

Conditions: Skin Infections, Bacterial

Summary: this is an open label, multi-centre, non-interventional post-marketing surveillance.

this is an open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety of altargo(retapamulin) treated in korean patients according to the prescribing information. altargo is a trademark of the glaxosmithkline group of companies.

Eligibility criteria:
inclusion criteria: * all subjects must satisfy the following criteria at study entry: 1. subjects administered with altargo(retapamulin) in the topical treatment of the following bacterial skin and skin structure infections (sssi) 2. subjects who the investigator believes that they can and will comply with the requirements of the protocol and follow the administration regimen 3. subjects administered with altargo(retapamulin) following the locally approved prescribing information exclusion criteria: * considering the nature of observational study, gsk korea encourages the doctors participating in this study to enrol the subjects prescribed with retapamulin following the locally approved prescribing information. 1. subjects with a known or suspected hypersensitivity to altargo(retapamulin) or any component of the ointment 2. infants under nine months of age

Keywords: impetigo secondarily-infected traumatic lesions retapamulin
casein glycomacropeptide in healthy subjects

Conditions: Gastrointestinal Disease

Summary: casein glycomacropeptide (cgmp) has anti-inflammatory properties in experimental rodent colitis and using human in vitro inflammation models. its use as a food ingredient has proven safe and with no influence on dietary intake. in a pilot study the investigators found, that orally administered cgmp seems to have a beneficial effect comparable to that of mesalazine in active distal ulcerative colitis. the investigators now wish to evaluate the effects in healthy subjects by studying the anti-inflammatory and microbiome modulating properties and by assessing possible changes in gastrointestinal symptoms.


Eligibility criteria:
inclusion criteria: * caucasians * body mass index 18.5-25.0 exclusion criteria: * within 3 months: acute intestinal disease (diarrhea more than 3 days in a week or bloody stools), hospital admission or antibiotic treatment. * chronic inflammatory disease or intestinal disease, including crohn's disease, ulcerative colitis, celiac disease, rheumatoid arthritis or any other autoimmune joint disease, multiple sclerosis or any intestinal surgery apart from appendectomy. * pregnant or nursing. * unable to speak and understand danish.

Keywords: glycopeptides dietary proteins whey protein caseinomacropeptide antiinflammatories human microbiome
the effect of preoperative anxiety on postoperative delirium in children

Conditions: Preoperative Anxiety; Postoperative Delirium

Summary: investigation of the effect of preoperative anxiety on postoperative delirium in children who will undergo circumcision operation

in order to determine the effect of circumcision on preoperative anxiety and postoperative delirium, patients will be divided into two groups who will undergo circumcision surgery and who will undergo inguinal hernia surgery. modified yale preoperative anxiety scores (m-ypas), visual analogue scale anxiety (vas-anxiety) will be evaluated when patients are taken to the preoperative waiting room. after awakening, patients will be taken to the postoperative wake-up room where pediatric anesthesia recovery delirium scores (paed), recovery agitation 5-point scores (ea), flacc scores will be evaluated every 5 minutes and mean arterial pressure, pulse, spo2 values will be recorded. duration of stay in recovery unit will be recorded

Eligibility criteria:
inclusion criteria: * asa 1-2 * elective circumcision or elective inguinal hernia exclusion criteria: * chronic diseases * development disability * prematurity * neurological diseases * psychoactive medication use * hearing/ visual impairment * history of surgery
cesarean trial of staples vs. sutures

Conditions: Cesarean Section; Wound Complications; Patient Satisfaction; Pain Measurement

Summary: to determine whether the rate of wound complications differs based on method of closure of skin incision (staples vs. suture) after cesarean delivery.

despite this large number of cesareans performed annually, there is a paucity of data to suggest which technique is superior for closure of the skin incision with regards to wound complications, including wound separation and infection. as the morbidity associated with a cesarean delivery is usually related to wound complications, especially infection, we feel that it is important to examine this outcome by comparing the current skin closure techniques: staples versus suture.

Eligibility criteria:
inclusion criteria: * women undergoing cesarean delivery for pregnancy greater than 23 weeks gestation. exclusion criteria: * poorly controlled diabetes (defined as ≥ 50% of fasting or 2 hour postprandial glucose levels \> 95 and 120 respectively within the week prior to delivery), * vertical skin incisions * chronic steroid use * active lupus flare * hiv/aids * current treatment for cancer or a history of radiation to the abdomen/pelvis * current treatment with immunosuppressant medications secondary to history of transplantation * emergency cesarean(precluding informed consent prior to surgery) * lack of access to a phone * allergy to suture or staple material

Keywords: staples sutures wound infections cosmesis aesthetic appearance of skin incision
an observational study evaluating the productivity and health-related quality of life of people with her2 positive breast cancer

Conditions: Breast Neoplasms

Summary: the purpose of this study is to compare productivity (in terms of work or daily activity) and generic and disease-specific health-related quality of life of participants with her2 positive early breast cancer currently receiving adjuvant treatment (with chemotherapy and/or targeted her2 therapy), with participants who have completed adjuvant parenteral therapy, and participants with her2 positive metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * diagnosed with early stage or metastatic (stage iv) her2-positive breast cancer (confirmed by the study site physician). \[her2-positive is defined as immunohistochemistry (ihc3+) and/or in situ hybridization (ish) ≥2.0\] * able to provide written, informed consent. * early stage breast cancer (ebc) patients must have received at least 1 cycle of adjuvant anti-cancer therapy following surgery; metastatic breast cancer (mbc) patients must have received at least 1 cycle of treatment for their metastatic disease. exclusion criteria: * unwilling or unable to consent. * unable to complete written quality of life questionnaires * partcipants with eastern cooperative oncology group (ecog) performance status ≥3
retrospective analysis of the french national cohort of patients with gad antibodies and cerebellar ataxia

Conditions: GAD-receptor Antibodies-associated Encephalitis

Summary: glutamic acid decarboxylase (gad) is an enzyme whose function in the body is to decarboxylate glutamate to gaba. gad65 antibodies (gad65ab) have been associated with type-1 diabetes (80% of new-onset patients) and various neurological conditions, mainly stiff-person syndrome (sps/perm), cerebellar ataxia (ca), limbic encephalitis (le) and temporal lobe epilepsy. these syndromes all seem to result from a reduced transmission of gaba. these neurological conditions are rare and can cause symptoms like confusion, memory loss, muscle stiffness, muscle spasms, behavioural disorders, and pharmacoresistant epilepsy. when finding high levels of gad65-ab in the serum, a cerebrospinal fluid (csf) sample should be taken to look for oligoclonal igg bands and intrathecal gad-ab production to prove an auto-immune cause for the various neurological symptoms.


Eligibility criteria:
inclusion criteria: * neurological symptoms with gad antibody * gad antibody in sera and/or csf * patient with cerebellar ataxia exclusion criteria: * tested positive to another antibody. * no data * any test in paraneoplastic neurological syndrome and autoimmune encephalitis center
a study to assess the efficacy and safety of tc-5214 as an adjunct therapy in patients with major depressive disorder

Conditions: Major Depressive Disorder; Depression

Summary: the purpose of this study is to determine if tc-5214 or placebo (a tablet that looks like medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with another antidepressant.

a multicenter, randomized, double-blind, parallel group, placebo-controlled, phase iii efficacy and safety study of tc-5214 (s-mecamylamine) in flexible doses as an adjunct to an antidepressant in patients with major depressive disorder who exhibit an inadequate response to antidepressant therapy

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent before initiation of any study-related procedures. * the patient must have a clinical diagnosis of major depressive disorder (mdd) with inadequate response to no more than one antidepressant. * out-patient status at enrollment and randomization. exclusion criteria: * patients with a lifetime history of bipolar disorder, psychotic disorder or post-traumatic stress disorder. * patients with a history of suicide attempts in the past year and/or seen by the investigator as having a significant history of risk of suicide or homicide. * history of renal insufficiency or impairment or conditions that could affect absorption or metabolism of the investigational product in this patient population

Keywords: major depressive disorder mdd depression safety add-on therapy